Hepatitis BPhase 1/2NCT00645294
Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV
A Phase 1/2 study testing Adefovir dipivoxil in people with Hepatitis B, run by Gilead Sciences at 10 sites in 4 countries.
Trial summary
Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Adefovir dipivoxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Feb 2003to Aug 2003
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females between the ages of 2 and 17 (inclusive) with chronic hepatitis B as evidenced by the following:
- HBsAg positive for a minimum of 6 months
- HBeAg positive and HBV DNA greater than or equal to 1 x 100,000 copies/mL at screening
- Children and adolescents with compensated liver disease
- ALT levels greater than or equal to 1.2 upper limit of normal (applicable to 7- to 17-year-old children and adolescents only)
Who cannot join
None listed.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany5 sites
J.W. Goethe-Universitat
Frankfurt, D-60590
Mid. Hochschule Hannover Kinderklinik
Hanover, D-30625
Kinderklinik der Gutenberg Universitat
Mainz, 55101
Standort Lindwurmstrasse
München, D-80337
Zentrum fur Kinder und Jugendmedizin der Klinikum
Wuppertal, D-42282
Poland2 sites
Oddzial Chorob Infekcyjnych Dzieci
Krakow, 31-202
Klinika Gastroenterologii
Warsaw, 04-730
United Kingdom2 sites
University of Birmingham
Birmingham, B4 6NH
King's College Hospital
London, England, SE5 9RY
About this study
Official title: A Phase 1-2 Open-Label Study of the Pharmacokinetics and Safety of a Single Dose of Adefovir Dipivoxil in Children and Adolescents (Aged 2-17) With Chronic Hepatitis B
Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.
Read the detailed description
Children and adolescents with chronic hepatitis B and compensated liver, HBeAg-positive and serum HBV DNA positive (greater than or equal to 1 x 100,000 copies/mL by Roche Amplicor Monitor PCR) received doses of adefovir dipivoxil in a cross-over design. Subjects aged 2-11 received two single doses (0.14 mg/kg and 0.3 mg/kg liquid formulation) and subjects 2-17 received one dose (10 mg liquid formulation).
- Conditions
- Hepatitis B
- Being tested
- Adefovir dipivoxil
- Keywords
- Hepatitis B, Adefovir dipivoxil, Children, Adolescents, Pharmacokinetics
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adefovir dipivoxilDrug
0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8
Adefovir DipivoxilDrug
0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8
Adefovir DipivoxilDrug
ADV 10 mg on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Other | ADV (0.14 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.3 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group Receives: Drug: Adefovir dipivoxil |
| Treatment Group B | Other | ADV (0.3 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.14 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group Receives: Drug: Adefovir Dipivoxil |
| Treatment Group C | Other | ADV 10 mg single dose on Day 1 in 12-17 year old age group Receives: Drug: Adefovir Dipivoxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the PK profile of adefovir 0.14 mg/kg and 0.3 mg/kg in children 2-11 years, including dose proportionality of adefovir dipivoxil liquid formulation. To characterize the PK profile of adefovir dipivoxil 10 mg in adoloscents 12-17 years.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startFeb 2003
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645294
- Sponsor's protocol ID
- GS-02-517
- Status last verified
- Mar 2008
- First submitted
- 21 Mar 2008
- Last updated
- 27 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2 Open-Label Study of the Pharmacokinetics and Safety of a Single Dose of Adefovir Dipivoxil in Children and Adolescents (Aged 2-17) With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00645294
- Acronym / sponsor ID
- GS-02-517
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Adefovir dipivoxil, Children, Adolescents, Pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.
Detailed description
Children and adolescents with chronic hepatitis B and compensated liver, HBeAg-positive and serum HBV DNA positive (greater than or equal to 1 x 100,000 copies/mL by Roche Amplicor Monitor PCR) received doses of adefovir dipivoxil in a cross-over design. Subjects aged 2-11 received two single doses (0.14 mg/kg and 0.3 mg/kg liquid formulation) and subjects 2-17 received one dose (10 mg liquid formulation).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Other | Drug: Adefovir dipivoxilADV (0.14 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.3 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group |
| Treatment Group B | Other | Drug: Adefovir DipivoxilADV (0.3 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.14 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group |
| Treatment Group C | Other | Drug: Adefovir DipivoxilADV 10 mg single dose on Day 1 in 12-17 year old age group |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males and females between the ages of 2 and 17 (inclusive) with chronic hepatitis B as evidenced by the following:
- HBsAg positive for a minimum of 6 months
- HBeAg positive and HBV DNA greater than or equal to 1 x 100,000 copies/mL at screening
- Children and adolescents with compensated liver disease
- ALT levels greater than or equal to 1.2 upper limit of normal (applicable to 7- to 17-year-old children and adolescents only)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adefovir dipivoxil0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8 | Drug | Treatment Group A |
| Adefovir Dipivoxil0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8 | Drug | Treatment Group B |
| Adefovir DipivoxilADV 10 mg on Day 1 | Drug | Treatment Group C |
Primary outcome
To characterize the PK profile of adefovir 0.14 mg/kg and 0.3 mg/kg in children 2-11 years, including dose proportionality of adefovir dipivoxil liquid formulation. To characterize the PK profile of adefovir dipivoxil 10 mg in adoloscents 12-17 years.
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adefovir dipivoxil in people with Hepatitis B, run by Gilead Sciences at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Poland, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the PK profile of adefovir 0.14 mg/kg and 0.3 mg/kg in children 2-11 years, including dose proportionality of adefovir dipivoxil liquid formulation. To characterize the PK profile of adefovir dipivoxil 10 mg in adoloscents 12-17 years. (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2008.